INTRAVASCULAR DELIVERY SYSTEM WITH CENTRALIZED STEERING

• US 20190030285A1
• Filed: 07/27/2017
• Published: 01/31/2019
• Est. Priority Date: 07/27/2017
• Status: Abandoned Application

• Current Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Inventors: Prabhu, Santosh V., Van Hoven, Dylan T., Gada, Manish B.
• Application Number:
  US15/662,084
• Publication Number:
  US 20190030285A1
• Time in Patent Office: Days
• CPC Class Codes: A61M 2025/015 Details of the distal fixation of the movable mechanical means
• CPC Class Codes: A61M 2025/0161 wherein the distal tips have two or more deflection regions
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/0141 having flexible regions as a result of using materials with different mechanical properties
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0152 with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes

Abstract

The present disclosure describes delivery systems for intravascularly delivering one or more interventional devices to a targeted treatment site within a patient'"'"'s body. A proximal end of a delivery catheter is coupled to a handle. One or more control lines extend from the handle through the delivery catheter to a coupler disposed at or near the distal end of the delivery catheter. Tensioning of the one or more control lines manipulates the coupler to form or adjust a compound curve in the delivery catheter.

Claims

1. A delivery system configured for delivery of an interventional device in an intravascular procedure, the delivery system comprising:

a handle having one or more controls;

a delivery catheter having a proximal end and a distal end, the proximal end being coupled to the handle, the delivery catheter having a proximal section and a distal section,

wherein at least the distal section is configured to selectively form a compound curve to enable positioning of the distal end relative to a targeted intravascular treatment site, and

wherein the compound curve includes a first curve formable at a proximal portion of the distal section and a second curve formable at a distal portion of the distal section;

one or more control lines each operatively coupled to a control of the handle and each extending from the handle through a wall lumen of the delivery catheter toward the distal end; and

a distal coupler disposed at or near the distal end of the delivery catheter, the one or more control lines extending to the distal coupler and engaging with the distal coupler such that tensioning of the one or more control lines changes position of the distal coupler to thereby form or adjust the compound curve.

2. The delivery system of claim 1, wherein the first curve and second curve lie in different planes.

3. The delivery system of claim 2, wherein the first curve lies in a plane that is substantially orthogonal to a plane in which the second curve lies.

4. The delivery system of claim 1, wherein the first curve is configured to be bendable to an angle of about 70 to about 120 degrees.

5. The delivery system of claim 1, wherein the second curve is configured to be bendable to an angle of about 10 to about 50 degrees.

6. The delivery system of claim 1, wherein the distal section has a length of about 2 to 6 inches, with the first curve being formed in the proximal most 1 to 3 inches, and the second curve being formed in the distal most 1 to 3 inches.

7. The delivery system of claim 1, wherein the first curve is pre-curved to an angle of about 30 to about 80 degrees.

8. The delivery system of claim 1, wherein the second curve is pre-curved to an angle of about 5 to about 30 degrees.

9. The delivery system of claim 1, wherein each control line extends from a control of the handle to the distal coupler and then loops back toward the handle.

10. The delivery system of claim 1, comprising a first pair of control lines circumferentially opposed to one another at the distal coupler, and a second pair of control lines circumferentially opposed to one another at the distal coupler, the first pair and the second pair being offset by about 90 degrees.

11. The delivery system of claim 1, wherein the delivery catheter includes an outer jacket of a braided material.

12. The delivery system of claim 11, wherein the outer jacket at the proximal section comprises two layers and at the distal section has a single layer.

13. The delivery system of claim 1, wherein the proximal section has a greater hardness rating than the distal section.

14. The delivery system of claim 13, wherein a catheter wall of the proximal section has a durometer of about 60D to about 90D, and wherein a catheter wall of the distal section has a durometer of about 35D to about 55D.

15. The delivery system of claim 1, wherein at least the distal section includes a region of preferential bending, wherein one side of the distal section is formed from a relatively less stiff material and the opposite side of the distal section is formed from a relatively stiffer material.

16. The delivery system of claim 1, further comprising an intermediate coupler disposed at the distal section at a location proximal of the distal coupler, and further comprising one or more intermediate control lines each operatively coupled to a control of the handle and extending to engage with the intermediate coupler and to enable manipulation of the intermediate coupler, manipulation of the intermediate coupler thereby controlling the first curve and manipulation of the distal coupler thereby controlling the second curve.

17. A delivery system configured for delivery of an interventional device in an intravascular procedure, the delivery system comprising:

a handle having one or more controls;

a delivery catheter having a proximal end and a distal end, the proximal end being coupled to the handle, the delivery catheter having a proximal section and a distal section,

wherein at least the distal section is configured to selectively form a compound curve to enable positioning of the distal end relative to a targeted intravascular treatment site,

wherein the compound curve includes a first curve formable at a proximal portion of the distal section and a second curve formable at a distal portion of the distal section, the first and second curves being formable in different planes,

wherein the first curve is pre-curved to an angle of about 30 to about 80 degrees and is configured to be further bendable to an angle of about 70 to about 120 degrees, and

wherein the second curve is pre-curved to an angle of about 5 to about 30 degrees and is configured to be further bendable to an angle of about 10 to about 50 degrees;

one or more control lines each operatively coupled to a control of the handle and each extending from the handle through a wall lumen of the delivery catheter toward the distal end; and

a distal coupler disposed at or near the distal end of the delivery catheter, the one or more control lines extending to the distal coupler and engaging with the distal coupler such that tensioning of the one or more control lines changes position of the distal coupler to thereby form or adjust the compound curve.

18. A method of delivering an interventional device intravascularly to a targeted treatment area, the method comprising:

providing a delivery system comprising;

a handle having one or more controls;

a delivery catheter having a proximal end and a distal end, the proximal end being coupled to the handle, the delivery catheter having a proximal section and a distal section, wherein at least the distal section is configured to selectively form a compound curve to enable positioning of the distal end relative to a targeted intravascular treatment site, and wherein the compound curve includes a first curve formable at a proximal portion of the distal section and a second curve formable at a distal portion of the distal section;

one or more control lines each operatively coupled to a control of the handle and each extending from the handle through a wall lumen of the delivery catheter toward the distal end; and

a distal coupler disposed at or near the distal end of the delivery catheter, the one or more control lines extending to the distal coupler and engaging with the distal coupler such that tensioning of the one or more control lines changes position of the distal coupler to thereby form or adjust the compound curve;

routing the distal end of the delivery catheter to the targeted treatment site; and

delivering the interventional device through a lumen of the delivery catheter.

19. The method of claim 18, wherein the first curve lies in a plane that is substantially orthogonal to a plane in which the second curve lies.

20. The method of claim 18, wherein the targeted treatment site is a mitral valve.